Kornimate/medical-research-clean huggingface dataset:
systemic treatment with everolimus for the prevention of mace after bare metal stent implantation

Conditions: Coronary Artery Disease; Coronary Restenosis

Summary: the purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative everolimus therapy compared to placebo in patients treated by bare metal stents for significant coronary artery disease. the aim is to reduce major adverse cardiac events (maces) including death, coronary artery bypass grafting (cabg) to the target vessel, q-wave and non-q-wave myocardial infarction, and target lesion revascularization within the first 6 months after intervention. additionally safety and tolerability of everolimus at the selected dose in this patient population will be analyzed.


Eligibility criteria:
inclusion criteria: 1. males or females, aged \>18 years. 2. patients with coronary artery disease who are scheduled for coronary intervention with bare metal stent placement for treatment of de novo or first restenosis in a native coronary artery. 3. target lesion must be in a native coronary vessel of 2.25 - 4.0 mm size. 4. target lesion has to be of less than or equal to 25 mm length. 5. tandem lesion may be included as long as: * overall length is less than or equal to 25 mm * tandem lesion will be treated with one stent and counted as one lesion. exclusion criteria: the following exclusion criteria must not be present at baseline visit 1 (bl1, screening visit prior to coronary intervention). if an exclusion criterion occurred afterwards, e.g., during the coronary intervention, the patient must be excluded from the study. 1. target lesion has a reference vessel size of less than 2.25 or more than 4.0 mm diameter. 2. target lesion is a total occlusion or located at a bifurcation. 3. treatment affords implantation of more than one stent per treated lesion. 4. target lesion was already treated by brachytherapy. 5. target lesion has one or more of the following criteria: * left main lesion * ostial lesion of the rca * located at less than 2 mm after the origin of the lad or rcx. other protocol defined inclusion/exclusion criteria may apply.

Keywords: coronary artery disease stents immunosuppressive agents coronary restenosis safety
using emergency manuals during interprofessional crisis management: are there unintended consequences?

Conditions: Safety Issues

Summary: despite increasing interest in emergency manuals (ems), relatively little is known about their effectiveness and limitations in the perioperative setting. prior studies have been limited in that they evaluated ems using crises that were tailor-made to match one of their chapters, and there has been minimal participation by attending surgeons and other experienced personnel. the investigators' preliminary experience suggests less-than-expected em use and suboptimal usage, which may be due to the simulation scenario falling "halfway between" two different chapters of the em, raising the question of whether limitations were due to the em content, team dynamics, or inadequate training in the em use. in this randomized, prospective, two-center simulation-based study, the investigators utilize clinical scenarios specifically designed to observe the patterns of use and to test the limitations of the ems. the hypothesis is that ems may not improve, and may even worsen, clinical performance in situations that do not exactly match a specific chapter of that em, and that em usage patterns will identify both strengths and limitations of the tools and its implementation. the participating healthcare providers consisting of experienced surgeons, anesthesiologists, and nurses will be randomized into four experimental groups, each exposed to either a "specific" or "non-specific" simulation scenario, along with or without the availability of the em. the major experimental endpoint will be how many "critical actions" each team performs, scored as the percentage of actions taken from a pre-determined list. the goal of this study is to improve em content and use by understanding its limitations during interprofessional team-training simulations and to study whether ems enhance or detract from clinical performance. this is especially a concern in situations that do not exactly match a specific chapter of the em, such as cases that are vague and represent multi-factorial diagnostic dilemmas such as hypotension and hypoxemia. the ultimate goal is to strengthen patient safety by providing guidance for improving em content, use, and training protocols.


Eligibility criteria:
inclusion criteria: * healthcare providers (anesthesiologists, surgeons, nurses) participating in the crisis management curriculum at each participating simulation site exclusion criteria: * those unwilling to be recorded during the simulation scenario

Keywords: emergency manual crisis checklist
working memory training for substance dependent individuals

Conditions: Substance Dependency; Addiction; Anxiety; Depression

Summary: background: substance abusers show impaired working memory (wm) functioning. promising findings show training wm results in an improved working memory capacity (wmc) and a decrease of clinical symptoms in a range of disorders, including alcohol addiction. aim: to test the effect of a wm training in addition to treatment as usual (tau) on substance use, craving, wmc, impulsivity, attention bias and psychopathology. design: a randomized double-blind placebo-controlled trial with a parallel group design. the wm training adapted to participants' wmc whereas the placebo training consisted of non-adaptive easy versions of these tasks. setting: two departments of an addiction treatment clinic in rotterdam, the netherlands. participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who were in treatment as usual . measurements: primary outcome measures: substance use and craving. secondary outcome measures: wmc, impulsivity, attention bias and psychopathology. participants were assessed before and after 24 sessions of wm training as well as two months after the training.


Eligibility criteria:
inclusion criteria: * substance dependency: cocaine, cannabis or alcohol exclusion criteria: * age below 16 or above 67 * current psychosis * neurological complaints

Keywords: substance abuse addiction working memory craving impulsivity attention control
study on high-sensitivity troponin 0h/1h for rapid diagnosis of non-st-segment elevation myocardial infarction in the chinese population

Conditions: Non-ST-segment Elevation Myocardial Infarction

Summary: the purpose of the study is to establish a high-sensitivity troponin 0h/1h process for the diagnosis of patients suspected of nstemi for the chinese population, obtain the inclusion and exclusion criteria for diagnosis of these patients and compare the new process with the existing diagnosing methods and processes, including the 3h and 6h processes more extensively used at present and the ecg combined with troponin diagnosis, so as to explore a confirmation model suitable for the chinese population.


Eligibility criteria:
inclusion criteria: 1. patients experiencing acute chest pain or angina pectoris symptom within 12 hours before visiting the hospital; 2. or those experiencing acute chest pain or angina pectoris peak within 12 hours before visiting the hospital. exclusion criteria: patients showing st-segment elevation during ecg and pregnant women.
prialt (ziconotide) in severe chronic pain

Conditions: Pain

Summary: the purpose of this study is to understand the effects of intrathecal ziconotide (an experimental pain medication) when the dose is slowly increased over a 3-week period in patients with severe chronic pain. during the weaning phase, the study will also gather information about switching from other intrathecal or it medication (slowly pumped directly into the space around the spine) to other systemic pain medication (by mouth or through the skin using a patch). after being weaned off current it medication, patients will be placed on it ziconotide or placebo (non-active substance) as well as being allowed a stable dose of systemic pain medications. patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol eln92045-352.


Eligibility criteria:
inclusion criteria: * patient is able to read, understand, and voluntarily sign the institutional review board (irb) approved, written informed consent document prior to the performance of any study-specific procedures; * patient must be male or female at least 18 years of age; * patient must have severe chronic pain for whom it therapy is warranted; * patient must be willing and able to comply with the protocol, and able to maintain the patient daily diary for opioid consumption; * patient must have an implanted programmable synchromed® infusion system in place for the treatment of chronic pain; * female patients of childbearing age agree to use adequate, appropriate contraceptive methods. males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods. exclusion criteria: * patient is pregnant or lactating; * patient has been on an investigational drug other than ziconotide or device within 30 days prior to the initiation of the study drug; * patients with a known hypersensitivity (allergy) to ziconotide or any of the excipients (other compounds) in the formulation; * patient has a condition that would contraindicate the use of it analgesia, including the presence of infection at the microinfusion injection site (where the needle is inserted in your abdomen to fill the pump with medication), uncontrolled bleeding diathesis (tendency for bleeding) and spinal canal obstruction that impairs circulation of cerebral spinal fluid.

Keywords: pain ziconotide prialt intrathecal synchromed
clinical study evaluating the safety and efficacy of esomeprazole in treatment of non-alcoholic steatohepatitis

Conditions: Fatty Liver Disease; Steatohepatitis, Nonalcoholic

Summary: the aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with nash through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.


Eligibility criteria:
inclusion criteria: both males and females. * diabetic and non-diabetic patients. * age \>18 years old. * overweight and obese patient: body mass index (bmi) ≥ 25 kg/ m2 but \<40 kg/ m2. * patients with heartburn, peptic ulcer, gastrointestinal reflux disease, erosive esophagitis, zollinger-ellison syndrome and helicobacter pylori infection. * patients with established diagnosis of nash based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (\>2 but \ 36, hair score of 2 or 3. exclusion criteria: * patients with a history of hypersensitivity to esomeprazole. * patients with bmi ≥ 40 kg/ m2. * patients taking warfarin, clopidogrel, digoxin, diazepam and phenytoin to avoid drug-drug interactions as these drugs are cyp2c19 substrates. * patients infected with human immune deficiency virus taking antiretroviral medicines or dosage forms containing rilpivirine. * patients with a history of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, wilson's disease and alpha-1 antitrypsin deficiency. * patients on medications associated with steatosis such as nsaids, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate. * patients with cancer or with a history of cancer. * patients with cardiovascular diseases. * pregnant and lactating females
evaluation of preterm infants fed post-discharge preterm infant formula

Conditions: Infant Development

Summary: this single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.


Eligibility criteria:
inclusion criteria: * gestational age at birth less than 37 weeks * birth weight less than 3200 g (approximately 7 pounds) * postmenstrual age is 34 0/7 through 41 0/7 weeks at enrollment * parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study * the currently-fed formula is a milk-based infant formula at a caloric density of ≤ 24 cal/fl oz. * singleton, twin, or triplet births only. * parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional. * participant's parent(s) has voluntarily signed and dated an icf, approved by an irb/iec and provided hipaa (or other applicable privacy regulation) authorization prior to any participation in the study. exclusion criteria: * an adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. * participant is taking and plans to continue taking medications, home remedies, herbal preparations, prebiotics or probiotics, rehydration solutions, or parenteral nutrition * participant is known to require elective surgery with hospitalization, other than uncomplicated outpatient surgery, during the course of the study. * participant is in another study that has not been approved as a concomitant study * participant has an allergy or intolerance to any ingredient in the study product * participant is currently receiving oxygen therapy * participant is currently receiving antibiotics * participant is currently receiving tube feedings
black walnuts and health

Conditions: Healthy

Summary: walnuts are a nutrient dense food, but most health research is on english walnuts (ew). black walnuts (bw) contain a different antioxidant and fatty acid profile, and more protein, compared to ew. the purpose of the study was to compare postprandial responses following the consumption of 3 breakfast meals containing either butter (control), bw, or ew.

this study was a randomized, double-blind control trial consisting of 3 study visits for 3 different treatments. the treatments were high-fat breakfast muffins containing either butter (control), black walnuts, or english walnuts. the investigators recruited healthy, normal-weight adults between the ages of 15 and 45y. study visits were completed in a random order with at least 72 hours between each visit. anthropometrics, questionnaires, and fasting and postprandial blood samples were collected at each visit. hypothesis: the walnut-containing meals would mitigate post-meal increases in glucose, insulin, triglycerides (tg), and lipid peroxidation while improving all measures of subjective appetite and tac compared to the traditional meal without nuts.

Eligibility criteria:
inclusion criteria: * healthy adult men and women * normal-weight (body mass index = 18-24.9kg/m2) exclusion criteria: * allergies to test meal ingredients (gluten, eggs, or nuts) * medication/supplement usage * chronic disease * pregnancy or plans to become pregnant * special diets * tobacco use
a double-blind, double-dummy, multicenter, randomized study of the efficacy and tolerability of valdecoxib 40 mg versus rofecoxib 50 mg in treating the symptoms of ankle sprain

Conditions: Acute Pain

Summary: the study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. the study also evaluated the disability status, tolerability and safety of these treatments.

a3471007 terminated early (30sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by merck \& co inc

Eligibility criteria:
inclusion criteria: * patients had sustained, no more than 48 hours prior to the first dose of study medication, a first- or second-degree ankle sprain of the lateral ligament, specifically: anterior talofibular ligament and/or posterior talofibular ligament and/or calcaneofibular ligament * at presentation, all patients were to have patient's assessment of ankle pain visual analog scale (vas) (0-100mm) of ≥45 mm in the orthostatic position on full weight bearing (ie, moderate to severe pain), had a minimum rating of 2 on the patient's global assessment of ankle injury and patient's assessment of normal function/activity * tthe investigator opinion was that each patient required, and was eligible for, therapy with an anti-inflammatory agent and/or analgesics to control symptoms exclusion criteria: none reported

Keywords: sprains and strains
telehealth remote patient monitoring study in people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: telehealth remote patient monitoring is a means of using communications technology - such as telephones, computers, and the internet - to connect patients remotely with their healthcare team from their homes. the investigators hope to learn more about improving healthy behaviors and blood glucose among persons with diabetes using telehealth remote patient monitoring technology to connect directly with nurse care coordinators. the purpose of this study is to evaluate a process for improving blood glucose and healthy behaviors among people with type 2 diabetes using telehealth remote patient monitoring technology with nurse care coordinators. some of the people in this study will work with a nurse care coordinator who will review your blood glucose weekly and call you at home every month for 3 months, while some of the people in this study will simply receive their normal care. at the end of the study, every participant will be asked questions about how they feel about their health care.


Eligibility criteria:
inclusion criteria: * enrolled in diabetes disease management program * ages 30-70 * hba1c between 7.5% and 10.9% in the previous six months * an internet or 3g connection and email address; * a working phone line (land line or cellular); and * ability to read and understand the english language. exclusion criteria: * taking insulin; * inability to independently engage in self-management behaviors (diagnosis of dementia, severe depression, schizophrenia, or cognitive impairment); * severe complications, which would preclude achieving an hba1c goal of 7% including diagnosis of the following: * severe stroke; * heart failure; * end-stage renal disease; * kidney dialysis; and * legally blind.

Keywords: type 2 diabetes self-management remote patient monitoring
right iliac fossa treatment-turkey audit

Conditions: Abdominal Pain; Appendicitis; Appendicitis Acute

Summary: background: acute appendicitis stands out as a frequently encountered surgical emergency. despite decades of experience and research, the diagnosis remains a formidable challenge, particularly in young females experiencing acute abdominal pain, where the assessment requires consideration of a broader spectrum of potential causes. an overarching concern lies in the risk of over-treatment, leading to an escalation in unnecessary surgeries, known as the negative appendectomy rate (nar). this elevated nar is associated with postoperative complications, prolonged hospital stays, and avoidable healthcare expenditures. despite international guidelines recommending the routine use of risk prediction models for patients with acute abdominal pain, reported nar values have reached as high as 28.2% in females and 12.1% in males. aim: the primary study aim is to identify optimal risk prediction models for acute rif pain in turkey. the secondary aims are to audit the normal appendicectomy rate, assess whether these scores have similar efficacy in immigrants, and demonstrate nationwide clinical trends to discuss possible improvements.


Eligibility criteria:
inclusion criteria: * all consecutive patients referred to general surgeons with right iliac fossa pain or suspected appendicitis. * all patients who undergo an appendicectomy during the study period. exclusion criteria: * previous appendicectomy, right hemicolectomy, or total colectomy. * previous abdominal surgery in the last 90 days. * pregnancy. * patients confirmed with covid-19.

Keywords: appendicitis appendectomy right iliac fossa abdominal pain
safety and performance evaluation of rewalk reciprocating gait orthosis (rgo)

Conditions: Paraplegia; Spinal Cord Injuries (SCI)

Summary: rewalk suit developed by argo medical technologies is designed to enable people with lower limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other pathologies that produce severe walking impairments.


Eligibility criteria:
inclusion criteria: * complete cervical (c7-8) or thoracic (t1-t12) spinal cord injury according to american spinal injury association (asia) guidelines * male and non-pregnant non-lactating female age 18-55 * at least 6 months after injury * regular use of rgo (reciprocating gait orthosis) or kafo's (knee ankle foot orthoses) or able to stand using a standing device (e.g., 'easy stand') * patients must be capable of providing informed consent * height of 160 to 190 cm * weight of \<100 kg exclusion criteria: * history of severe neurological injuries other than sci (spinal cord injuries)(ms (multiple sclerosis), cp (cerebral palsy), als (amyotrophic lateral sclerosis) , tbi (traumatic brain injury) etc) * severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores * severe spasticity (ashworth 4) or uncontrolled clonus * unstable spine or unhealed limbs or pelvic fractures * heterotopic ossification * significant contractures * psychiatric or cognitive situations that may interfere with the trial

Keywords: rewalk paraplegia spinal cord injuries (sci)